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Effects of Sleep Duration and Architecture on Insulin Sensitivity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by University of California, San Francisco.
Recruitment status was:  Recruiting
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: July 15, 2011
Last updated: October 25, 2014
Last verified: October 2014

This pilot clinical trial will test the hypotheses that sleep restriction (for 5 nights), in comparison to "normal sleep", will:

  1. Decrease peripheral insulin sensitivity and glucose tolerance, as measured by the hyperinsulinemic-euglycemic clamp and oral glucose tolerance test.
  2. Decrease hepatic insulin sensitivity, as assessed by stable isotope studies of endogenous glucose production, gluconeogenesis and glycogenolysis.

Condition Intervention
Insulin Resistance
Behavioral: Sleep restriction

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effects of Sleep Duration and Architecture on Insulin Sensitivity

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 1 month ]
    Peripheral insulin sensitivity will be measured using the hyperinsulinemic-euglycemic clamp. Hepatic insulin sensitivity will be measured using stable isotope tracer studies.

Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sleep restriction
The investigators will compare the effects of sleep restriction vs. normal sleep in healthy volunteers, using a randomized crossover study design. Each subject will undergo a period of normal sleep and a period of sleep restriction, separated by a 1-month washout period. Subjects will be randomized to receive either sleep restriction first (later followed by normal sleep) or normal sleep first (later followed by sleep restriction).
Behavioral: Sleep restriction
Sleep restriction will consist of 5 nights, sleeping 4 hours per night Normal sleep will consist of 5 nights, sleeping 9 hours per night

Detailed Description:

Over the past 50 years, the incidence of diabetes has increased dramatically, while sleep duration in the US has decreased significantly. Epidemiological studies and small clinical trials suggest that these trends are causally related. In this study, our goal is to determine the mechanisms by which decreased sleep duration directly affects insulin sensitivity. The investigators will perform a clinical study in 20 healthy volunteers to determine whether 5 nights of sleep restriction decreases insulin sensitivity in the peripheral tissues (ie, skeletal muscle) or liver.

Peripheral insulin sensitivity will be measured by the hyperinsulinemic-euglycemic clamp, and hepatic insulin sensitivity will be quantified by measurement of hepatic glucose production, gluconeogenesis and glycogenolysis (using stable isotope tracer methods). Subjects will be randomized to an initial period of "normal sleep" or sleep restriction and will be admitted to the Clinical Research Center (CRC) for 9 days to undergo comprehensive metabolic studies and sleep assessments under the assigned sleep condition. After a 1-month washout period, subjects will be re-admitted to the CRC to undergo these same assessments under the opposite sleep condition.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-45 years
  • Regular work hours (ie, no night-time or shift work within the past 6 months)
  • Pittsburgh Sleep Quality Index (PSQI) Score <5
  • Average nightly sleep duration 6-9 hours (per screening actigraphy)

Exclusion Criteria:

  • Current or prior diabetes, gestational diabetes, impaired glucose tolerance or impaired fasting glucose
  • Type 2 diabetes in biological parents
  • BMI >=25
  • Pregnancy
  • Chronic medical condition, including: psychiatric disorders, heart disease, pulmonary disease, infectious diseases, rheumatological and neurological disorders
  • Use of prescribed medications on a regular basis.
  • History of disorder involving hypothalamic, pituitary or adrenal glands
  • History of or current sleep disorders (insomnia, restless leg syndrome, sleep disordered breathing, narcolepsy, etc)
  • Anemia
  • Cognitive impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01396941

United States, California
UCSF San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Madhu N. Rao, MD    415-206-6381   
Principal Investigator: Madhu N. Rao, MD         
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Madhu N. Rao, MD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco Identifier: NCT01396941     History of Changes
Other Study ID Numbers: K23HL096832 ( US NIH Grant/Contract Award Number )
Study First Received: July 15, 2011
Last Updated: October 25, 2014

Keywords provided by University of California, San Francisco:

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 28, 2017